Association Between Health-Related Quality of Life Measures and Survival Endpoints in Oncology Clinical Trials and in Clinical Decision Making: A Narrative Review.

For decades, oncology research has primarily relied on survival-based endpoints, such as progression-free survival and overall survival, to evaluate treatment efficacy. However, recent studies and international guidelines underscore the importance of incorporating patient-reported outcomes through patient-reported outcomes measures (PROMs). PROMs provide a more comprehensive view of treatment effectiveness, integrating the concepts of 'living longer' and 'living better.

Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan.

Background: Metastatic triple-negative breast cancer (BC; mTNBC) is one of the most aggressive cancers, difficult to treat due to the absence of hormone target receptors. Sacituzumab govitecan (SG) is a new therapeutic approach that exploits the combination of an antibody directed against the Trop-2 antigen expressed in solid epithelial tumors and the active metabolite SN-38, to precisely target cancer cells. The development of consensus recommendations requires synthesizing expert opinions, especially when direct evidence is limited.

Press releases of industry-sponsored clinical trials in oncology: Characteristics, timing and financial impact.

Background: Press releases (PRs) anticipate the results of a clinical trial, possibly without providing detailed data. The purpose of this analysis was to describe the characteristics of PRs in oncology, delays in the availability of results and the impact on the financial market.

Materials And Methods: PRs published between 2018 and 2022 about solid tumors, archived on the websites of the top 20 oncology pharmaceutical companies, were screened.

Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project.

Background: Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer (BC) specific comprehensive archive of PROMs.

Gut and local microbiota in patients with cancer: increasing evidence and potential clinical applications.

In recent years, cancer research has highlighted the role of disrupted microbiota in carcinogenesis and cancer recurrence. However, microbiota may also interfere with drug metabolism, influencing the efficacy of cancer drugs, especially immunotherapy, and modulating the onset of adverse events. Intestinal micro-organisms can be altered by external factors, such as use of antibiotics, proton pump inhibitors treatment, lifestyle and the use of prebiotics or probiotics.

Management of cancer treatment-induced bone loss in patients with breast and hormone sensitive prostate cancer: AIOM survey.

Purpose: Cancer treatment-induced bone loss is a side effect of hormonal therapy that can severely affect patients' quality of life. The aim of this survey was to obtain an updated picture of management of bone health in patients with breast cancer undergoing adjuvant hormonal therapy and in patients with hormone sensitive prostate cancer according to Italian oncologists.

Methods: Our survey was made up of 21 multiple-choice questions: the first part dealt with the respondents' characteristics, while the second with management of bone health in the described setting.

Treatment of bone metastases from solid tumors with bone-modifying agents: a web survey of Italian oncologists investigating patterns of practice drug prescription and prevention of side effects.

Purpose: Optimal use of bone-modifying agents (BMAs) in patients with bone metastases from solid tumors is uncertain in some aspects: the drug choice; the planned treatment duration and long-term therapy; the prevention and management of possible side effects, including renal toxicity, hypocalcaemia, and medication-related osteonecrosis of the jaw (MRONJ).

Methods: Italian oncologists were invited to fulfil a 24-question web survey about prescription of BMAs for bone metastases of breast cancer, prostate cancer, and other solid tumors. Prevention and management of side effects were also investigated.

Frequency of Germline and Somatic and Mutations in Prostate Cancer: An Updated Systematic Review and Meta-Analysis.

In prostate cancer (PC), the presence of somatic and/or germline mutation provides prognostic and predictive information. Meta-analysis aims to estimate the frequency of mutations in patients with PC (PCp). In November 2022, we reviewed literature searching for all articles testing the proportion of mutations in PCp, without explicit enrichment for familiar risk.

Clinical value of offering multiple chemotherapy lines to a luminal-like metastatic breast cancer: A case report with eribulin.

Introduction: The achievement of complete response with chemotherapy after multiple treatment lines in metastatic breast cancer and the chemosensitivity in a luminal-like breast cancer are two important issues as it is often asked whether there is a potential limit to the number of therapeutic lines offered and what clinical value they may have. In this setting, eribulin mesylate is a chemotherapy option available. Several randomized and observational studies demonstrated eribulin's meaningful improvement on prolongation of survival, chronicling the disease and preventing the onset of new metastases, although the rate of complete responses is rather limited.

MEK inhibitor as single agent in low grade serous ovarian and peritoneal cancer: a systematic review and meta-analysis.

Background: Low grade serous carcinoma of the ovary and peritoneum (LGSC) is characterized by low response rates to chemotherapy and by MAPK pathway alterations. Phase II/III clinical trials tested different MEK inhibitors (MEKis) in this complex malignancy, with heterogenous results. Purpose of this systematic review and meta-analysis is to define activity and efficacy of these agents and explore differences in clinical outcomes related to RAS/RAF mutational status.

Management of Metastatic Endometrial Cancer: Physicians' Choices Beyond the First Line. A MITO Survey.

Background: Endometrial cancer (EC) therapeutic and diagnostic approaches have been changed by the development of a new prognostic molecular classification, the introduction of dostarlimab in microsatellite instability (MSI) high pre-treated advanced EC patients with further expected innovation deriving from lenvatinib plus pembrolizumab regardless MSI status. How this is and will be translated and embedded in the clinical setting in Italy is not known; this is why we developed Multicentre Italian Trials in Ovarian cancer and gynaecologic malignancies (MITO) survey on the current practice and expected future changes in EC.

Methods: We designed a self-administered, multiple-choice online questionnaire available only for MITO members for one month, starting in April 2021.

Immunotherapy for Cervical Cancer: Are We Ready for Prime Time?

The prognosis of invasive cervical cancer (CC) remains poor, with a treatment approach that has remained the same for several decades. Lately, a better understanding of the interactions between the disease and the host immune system has allowed researchers to focus on the employment of immune therapy in various clinical settings. The most advanced strategy is immune checkpoint inhibitors (ICIs) with numerous phase II and III trials recently concluded with very encouraging results, assessing single agent therapy, combinations with chemotherapy and radiotherapy.

Biomarkers of Central Nervous System Involvement from Epithelial Ovarian Cancer.

Epithelial ovarian cancer (EOC) is the leading cause of death among women affected by gynaecological malignancies. Most patients show advanced disease at diagnosis (FIGO stage III-IV) and, despite the introduction of new therapeutic options, most women experience relapses. In most cases, recurrence is abdominal-pelvic; however, EOC can occasionally metastasize to distant organs, including the central nervous system.